510(k) K141834
K141834 is an FDA 510(k) premarket notification submitted by Q Core Medical , Ltd. for the device "SAPPHIRE ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on Aug 5, 2014. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Q Core Medical , Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2014
- Date Received
- Jul 7, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)